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EFSA's handling of the review of the Threshold of Toxicological Concern (TTC)


1. EFSA did not base the approval of the TTC on current scientific knowledge, thereby, infringing its own values.

EFSA did not fully explain why the TTC approach was chosen, how it took into account scientific insights of the past 15-20 years and why alternative assumptions were discarded.

2. By endorsing the TTC approach, EFSA infringed EU law.

Specifically, the complainant argued that EFSA excluded 5% of the most dangerous chemicals from the TTC tool and it thereby infringed the precautionary principle enshrined in Article 191 TFEU and Article 1.4 of Regulation 1107/2009.

3. By inviting experts in a conflict of interest situation to review the TTC approach, EFSA lacked independence and objectivity.

Specifically, EFSA failed to observe its independence policy as several of the experts involved have been part of the "industry lobby group", the International Life Sciences Institute (ILSI). Certain of the experts were, in fact, involved in the steering committee on FOSIE, an ILSI programme to develop TTC and other "threshold tools".


1. EFSA should withdraw the 2016 review on TTC and start a new, full review of TTC using independent experts. Pending the outcome of that review, EFSA should not use TTC in risk assessment.

2. EFSA should review its policy on independence and objectivity.

3. EFSA should refer the risk management aspects of TTC, such as the cut-off level of 5%, to the European Commission.